Last updated: 07/10/2020 18:50:05

A Study To Investigate GW427353 In Subjects With Irritable Bowel Syndrome (IBS)

GSK study ID
B3I105940
See study documents
Clinicaltrials.gov ID
NCT00394186
EudraCT ID
2005-006118-17
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Double-Blind, Placebo-Controlled, Crossover, Phase IIa Study to Evaluate Efficacy and Safety of the beta-3-Adrenergic Receptor Agonist Solabegron in Subjects with Irritable Bowel Syndrome
Trial description: This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, will relieve IBS pain or discomfort and associated symptoms in IBS patients.
Primary purpose:
Diagnostic
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

completion of questionnaires by the subject, determining the average adequate relief rate

Timeframe: during the last 4 weeks of the treatment periods (weeks 3 to 6 in period 1 and weeks 15-18 in period 2)

Secondary outcomes:

Blood levels of GW427353

Timeframe: Week 1, 13

Questionnaire

Timeframe: Weeks 1, 6, 12, 18, 24

ECG, vital signs, adverse events

Timeframe: each visit

clinical lab tests

Timeframe: Weeks 1, 6, 12, 18, 24

Interventions:
  • Drug: GW427353
  • Drug: Placebo
    • Enrollment:
    100
    Primary completion date:
    2007-14-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Irritable Bowel Syndrome (IBS)
    Product
    solabegron
    Collaborators
    Not applicable
    Study date(s)
    August 2006 to June 2007
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 Years
    Accepts healthy volunteers
    no
    • Diagnosis of IBS which meets the Rome II criteria, screening pain score to be > 1.5 (0= no pain, 4 = very severe pain)
    • Subjects not meeting the Rome II criteria for the diagnosis of IBS
    • Subjects with no stool for 7 days during the screen
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Diagnosis of IBS which meets the Rome II criteria, screening pain score to be > 1.5 (0= no pain, 4 = very severe pain)
    Exclusion criteria:
    • Subjects not meeting the Rome II criteria for the diagnosis of IBS
    • Subjects with no stool for 7 days during the screen

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Adelaide, South Australia, Australia, 5000
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Box Hill, Victoria, Australia, 3128
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Caboolture, Queensland, Australia, 4510
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Concord, New South Wales, Australia, 2139
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kippa Ring, Queensland, Australia, 4021
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Malvern, Victoria, Australia, 3144
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 7 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2007-14-06
    Actual study completion date
    2007-14-06

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website